https://www.avient.com/sites/default/files/2022-07/Lewiston 308872_en_13485_21%5B43%5D.pdf
Lewiston, ME, 04240 United States of America Scope Avient CAI Design and manufacture of colour and additive concentrates and specialty compounds for the Healthcare and Medical device market. Normative base EN ISO 13485:2016 Medical devices – Quality Management System Reg. no. 45484 Validity 01.03.2022 – 28.02.2025 Issue 01.03.2022 Swiss Made Swiss Association for Quality and Management Systems (SQS) Bernstrasse 103, 3052 Zollikofen, Switzerland sqs.ch F.
https://www.avient.com/sites/default/files/2023-10/308659_en_46154.pdf
Ltd. 30, Hsing Pang Road 33068 Taoyuan Taiwan Scope Design and manufacture of colour and additive concentrates and specialty compounds for the Healthcare and Medical device market. Normative base EN ISO 13485:2016 Medical devices – Quality Management System Reg. no. 46154 Validity 12.01.2022 – 11.01.2025 Issue 12.01.2022 Swiss Made Swiss Association for Quality and Management Systems (SQS) Bernstrasse 103, 3052 Zollikofen, Switzerland F.
https://www.avient.com/products/polymer-additives/fiber-additives/cesa-fiber-additives
Learn how one manufacturer used compliant Cesa™ Fiber Additives in nonwoven medical face masks Explore the power of polymer solutions for hygiene & medical nonwovens Discover how Avient's polymer colorants and additives can help increase the performance and appeal of nonwovens used in hygiene and medical applications
https://www.avient.com/sites/default/files/resources/PolyOne%25202013%2520Annual%2520Report.pdf
Global Corporate Account Director, Dow Advanced Materials, The Dow Chemical Company (a global provider of chemicals and plastics) July 2009 to May 2010, Global Strategic Marketing Director, Dow Coating Solutions, The Dow Chemical Company, March 2008 to July 2009. Global Business Director, Polypropylene, The Dow Chemical Company, May 2007 to March 2008. Global Marketing Executive, UCON™ Fluids and Lubricants, The Dow Chemical Company, March 2002 to May 2005. 20 POLYONE CORPORATION PART II ITEM 5.
https://www.avient.com/sites/default/files/2021-04/versaflex-hc-bt218-biopharmaceutical-tubing-case-study.pdf
MEDICAL TUBING EXTRUDER B I O P H A R M A C E U T I C A L T U B I N G • Low leachables & extractables • Great tensile performance and kink resistance • Good thermal weldability • Excellent clarity and medical blue tint • ISO 10993-4 & 5, USP Class VI & Animal Derivative Free (ADF) • Supplied drop-in material replacement to overcome supply constraints of incumbent TPE • Offered a lower extractable profile than comparable materials in the market • Enabled easy material transition without changes in tooling or thermal welding machine settings • Formulated solution with proprietary additives to provide clarity and prevent yellowing after sterilization Versaflex™ HC BT218 Thermoplastic Elastomer KEY REQUIREMENTS WHY AVIENT?
https://www.avient.com/sites/default/files/2025-01/Stethoscope Dispersions Case Study Snapshot.pdf
MEDICAL DEVICE MANUFACTURER S T E T H O S C O P E S • Provide a silicone paste colorant dispersion for liquid silicone rubber (LSR) to use in stethoscope ear tips • Create a custom-colored vinyl plastisol formulation for stethoscope tubing • Harmonize color across materials to meet specific process and performance requirements • Deliver effective communication and cross-functional collaboration • Offered dependable silicone paste colorants that allowed for comfort and easy sterilization • Provided a colored vinyl plastisol to reduce tackiness and support product longevity • Collaborated internally to align all materials and provide color consistency across components • Supported fast color changes and met quality specifications through constant communication and technical expertise Silcopas Silicone Paste Colorants and CORE Vinyl Plastisols for Healthcare KEY REQUIREMENTS WHY AVIENT? https://www.avient.com/products/vinyl-formulations/vinyl-plastisols-organosols/core-vinyl-plastisols-healthcare https://www.avient.com/products/polymer-colorants/colorant-dispersions/colorants-liquid-silicone-rubber Slide 1: Medical device manufacturer
https://www.avient.com/sites/default/files/2025-01/ISO 13485 Shanghai %28ZhangJiang%29%2C China.pdf
240625-2017-AQ-RGC-NA-PS Initial certification date: 14 September 2017 Valid: 08 February 2025 – 07 February 2028 This is to certify that the management system of PolyOne-Shanghai, China 88 Guoshoujing Road, Z.J.Hi-Tech Park, Pudong Shanghai, China (Unicode: 91310000607342402D) has been found to conform to the Quality Management System standard: ISO 13485:2016 This certificate is valid for the following scope: Design, Manufacture, Sales and Distribution of Medical Colour and Additive Concentrates Used for the Plastic Parts of Medical Devices http://www.dnv.com
https://www.avient.com/sites/default/files/2022-12/Mevopur Healthcare Colorants and Formulations_Functional Additives for IVD Devices Bulletin.pdf
Fast, accurate and reliable results aid medical professionals to understand the illness and develop the strategy for an effective treatment. It is the responsibility of the medical device manufacturer and the person placing the medical device on the market to ensure compliance of the medical device with all applicable laws and regulations, including the suitability of all raw materials and components used for its manufacture.
https://www.avient.com/resource-center?document_type=59&document_subtype=117
Disinfectant Resistance for Medical Device Housings - Case Study Manufacturer boosts disinfectant resistance for medical device housings using Trilliant HC High Performance Formulations
https://www.avient.com/resources/safety-data-sheets?page=4409
MEDICAL ORANGE PE MEDICAL GREEN PE